TWILIGHT Analysis Highlights Sex Disparities in PCI Treatment, Outcomes

Investigators discuss observed outcomes in females with high-risk PCI treatment, and their continued underrepresentation in pharmacologic studies.

New findings from a prespecified secondary analysis of the TWILIGHT study highlight sex-based disparities in bleeding risk, and similarities in ischemic events and aspirin benefit, among patients of percutaneous coronary intervention (PCI) who were treated with ticagrelor and aspirin.

The analysis, presented at the American College of Cardiology (ACC) 2021 Scientific Sessions this weekend, showed women—who comprised just 23.9% of the 7119-participant TWILIGHT population—reported greater bleeding risks than men primarily due to baseline differences in the 2019-published trial.

However, ischemic events including composite death, myocardial infarction or stroke were similar across both sexes with high-risk PCI.

Additionally, early aspirin withdrawal plus continued ticagrelor treatment over 12 months was associated with similarly lowered bleeding risks in men and women.

In an interview with HCPLive, study authors Birgit Vogel, MD, and Roxana Mehran, MD, both of the Icahn School of Medicine at Mount Sinai, discussed the sex-based treatment and risk implications derived from the outcomes.

“For the ischemic outcome, we found one significant interaction between treatment strategy and sex—and that was that in women, the mortality was significantly decreased with the ticagrelor monotherapy strategy compared to the continued (dual-acting platelet therapy), but this was not the case in men,” Vogel said.

Vogel explained that the observed similar relative risk reduction for bleeding, when considered with the overall higher risk of bleeding among women with high-risk PCI, would constitute a greater response to the observed therapy for bleeding risk reduction in women.

Contributing to the point of the secondary analysis’ significance in PCI treatment understanding, Mehran highlighted the continued underrepresentation of women patients in cardiovascular research—despite the burden of such diseases on the sex.

“I think that the TWILIGHT sex analysis underlines the importance of making sure that we absolutely perform sex-based analyses on large, prospective clinical trials that examine pharmacologic revascularization or device strategies in patients,” she said. “Overall, we’re underpowered to evaluate the effectiveness in women.”

The study, “Sex Differences Among Patients With High Risk Receiving Ticagrelor With or Without Aspirin After Percutaneous Coronary Intervention,” was published online in JAMA Cardiology.